| CTRI Number |
CTRI/2024/07/071006 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of oral administration of Nimbashatka choorna and Nimba malahara lepa with Vidangadi choorna and Nimba malahara lepa in itching per vagina. |
|
Scientific Title of Study
|
A randomized open-labelled comparative clinical study to evaluate the efficacy of oral administration of Nimbashatka choorna and Nimba malahara lepa with Vidangadi choorna and Nimba malahara lepa in Acharana yonivyapat with special reference to pruritus vulvae |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopika P |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082
Bangalore KARNATAKA 560082 India |
| Phone |
9497707579 |
| Fax |
|
| Email |
pannikotegopika2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rachana HV |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082
Bangalore KARNATAKA 560082 India |
| Phone |
9535744077 |
| Fax |
|
| Email |
dr.rachanabhat@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gopika P |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082
Bangalore KARNATAKA 560082 India |
| Phone |
9497707579 |
| Fax |
|
| Email |
pannikotegopika2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Gopika P |
| Address |
Sri Sri College of Ayurvedic Science and Research, Kanakpura Road, Udayapura P.O,560082 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri College of Ayurvedic Science and Research |
Kanakpura Road, Udayapura P.O,560082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gopika P |
Sri Sri College of Ayurvedic science and Research Hospital |
Department of Prasuti Tantra and Stree Roga, Room No. 10, Sri Sri College of Ayurvedic science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082, Karnataka Bangalore KARNATAKA |
9497707579
pannikotegopika2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L292||Pruritus vulvae. Ayurveda Condition: ACARANA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VIDANGADI CHURNA, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: -(2) Medicine Name: NIMBA MALAHARA LEPA, Reference: KAIYYADEVA NIGHANTU, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NIMBASHATKA CHURNA, Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: -(2) Medicine Name: NIMBA MALAHARA LEPA, Reference: KAIYYADEVA NIGHANTU, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1)Subjects irrespective of marital status
2) Subjects in perimenopausal and post-menopausal age group
3)Subjects diagnosed with classical symptoms of Acharana yonivyapath
4)Subjects with classical symptoms of Pruritus vulvae.
5)Subjects willing to sign the consent form |
|
| ExclusionCriteria |
| Details |
1.Subjects who are pregnant and lactating mothers.
2.Subjects during the time of menstruation.
3.Subjects with uncontrolled diabetes mellitus.
4.Subject with known case of sexually transmitted diseases.
5.Subject with known case of benign and malignant conditions.
6.Subject with known case of systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is significant decrease in Pruritus vulvae which will be assessed based on 5-D Pruritus scale |
Pre assessment 0th day
1st assessment On 7th day
Follow up On 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in-depth analysis of duration, degree, direction, disability & distribution of Pruritus vulvae
Generation of data on possible unexpected drug reaction.
|
0th day to 15th day
|
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Throughout history, the central role of women in society has ensured the stability, progress and longterm development of nations. Today, the median female shares of the global workplace is 45.4% wherein the role of women in the urban and rural workforce has expanded exponentially in recent decades . It is, therefore, important to focus on women and their health. In this regard, Ayurveda plays an important role in preserving the comprehensive wellbeing of a woman. And this study aims at targeting one such ailment in Gynaecology. Improper hygiene (Adhavana) of yoni leads to the formation of Jantu which in turn leads to excessive itching in the Yoni and this condition is termed as Acharana Yonivyapath. A similar entity in modern classics, where there is excessive itching in the vulvar region is termed as Pruritus Vulvae. Pruritus Vulvae is a symptom which is experienced by not less than 10% of women attending gynecological clinics. If not treated properly, profound itching in Vulval Pruritus leads to uncontrollable scratching, which results in conditions like Lichen simplex chronicus, now called Hyperplastic vulval dystrophy. Many modern medications like anti-fungal, antibacterial, corticosteroids, local anaesthetic agents have been in use for this condition. But they have their own side effects. In Ayurvedic classics, there are many references to treat Kandu. Among them, oral administration of Nimbashatka choorna and Vidangadi choorna is said to be effective in Pruritus Vulvae. Nimbashatka choorna contains Nimba, Kutaja, Saindhava, Hingu, Vidanga and Ramata and Vidangadi choorna with ingredients Vidanga, Triphala and Krishna are indicated in Kustha, Krimi, Meha, Nadi vrana and Bhagandara. Both the Choornas are selected for the study because of their Krimighna and Kandughna property. Nimba Malahara lepa is a topical application of medicated ointment where in the duration of drug application is more compared to lepa. Nimba being Krimihara, Kaphahara and Kandughna is the best drug of choice for Lepana. External application of Nimba added with the oral medicines facilitates easier as well as faster recovery from the symptoms. This study therefore, intends to aid diagnosis and rationalize prescribing, to find a sure shot treatment for Acharana Yonivyapath. |